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Title: MO-F-16A-08: Have An Impact On More Patients From Your Ideas And Inventions

Purpose: To inform physicists how to obtain an FDA 510(k) clearance for the innovations they use in their facility and to make those ideas widely available to patients throughout the U.S. Methods: Give advice from 20 years experience of assisting in well over 100 successful 510(k) clearances. Results: Learn how to develop a 510(k) submission. Conclusion: Many physicists, physicians and radiation therapists have developed innovations that that are helpful to the patients in their institution. But, many of these innovations deserve to be made available to patients throughout the United States. The author, a Certified Radiological Physicist and former FDA employee, has consulted for over twenty years for inventors, start-ups and established medical device manufacturers to bring new devices to market in the U.S. and to assist them to established FDA compliant quality systems for manufacturing. In this presentation the audience will learn the important points for deciding to go forward with obtaining a Premarket Notification clearance [also known as a 510(k) clearance] to legally market a medical device in the United States. The FDA has published guidelines for submitting a 510(k) application. However, the methods used to efficiently develop the documentation for submission and to obtain clearance in themore » shortest possible time comes from the author's experience in assisting well over one hundred successful 510(k) clearances.Whether you want to start your own company or to market your idea to an established medical device manufacturer, the value of your innovation increases with a documented 510(k) clearance from FDA.« less
Authors:
 [1]
  1. Quality and Regulatory Services, Inc., Lincoln, CA (United States)
Publication Date:
OSTI Identifier:
22407908
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 41; Journal Issue: 6; Other Information: (c) 2014 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
61 RADIATION PROTECTION AND DOSIMETRY; EQUIPMENT; HEALTH SERVICES; INVENTIONS; LEGAL ASPECTS; PATIENTS; RADIOLOGY; RECOMMENDATIONS; USA